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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003239-36 | EudraCT Number | ||
| JAVELIN OVARIAN 100 | Other Identifier | Alias Study Number |
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The study was terminated based on the results of a planned interim analysis that showed futility of efficacy.
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This is a Phase 3, open-label, international, multi-center, efficacy, and safety study of avelumab in combination with and/or following platinum-based chemotherapy. Eligible patients must have previously untreated, histologically confirmed Stage III-IV epithelial ovarian (EOC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) and be candidates for platinum-based chemotherapy.
The primary purpose of the study is to demonstrate if avelumab given as single agent in the maintenance setting following frontline chemotherapy or in combination with carboplatin/paclitaxel is superior to platinum-based chemotherapy alone followed by observation in this population of newly diagnosed ovarian cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Active Comparator | Chemotherapy followed by observation |
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| Arm B | Experimental | Chemotherapy followed by avelumab in maintenance |
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| Arm C | Experimental | Chemotherapy in combination with avelumab followed by avelumab in maintenance |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | Given Q3W during chemotherapy phase |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) | BICR assessed PFS: Duration from randomization until disease progression or death. PFS data was censored on the date of the last adequate tumor assessment for participants who did not have an event (progression of disease or death), who started a new anti-cancer therapy prior to an event or for participants with an event after 2 or more missing tumor assessments. Progression as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1: as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method. | Baseline to progression of disease or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival was defined as the time (in months) from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method. | Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 27 months) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Bradley Monk, MD | Department of Obstetrics and Gynecology University of Arizona Cancer Center, USA | Study Chair |
| Jonathan Ledermann, MD | UCL Cancer Institute, UK | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Oncology | Alabaster | Alabama | 35007 | United States | ||
| Alabama Oncology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34363762 | Derived | Monk BJ, Colombo N, Oza AM, Fujiwara K, Birrer MJ, Randall L, Poddubskaya EV, Scambia G, Shparyk YV, Lim MC, Bhoola SM, Sohn J, Yonemori K, Stewart RA, Zhang X, Perkins Smith J, Linn C, Ledermann JA. Chemotherapy with or without avelumab followed by avelumab maintenance versus chemotherapy alone in patients with previously untreated epithelial ovarian cancer (JAVELIN Ovarian 100): an open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Sep;22(9):1275-1289. doi: 10.1016/S1470-2045(21)00342-9. Epub 2021 Aug 4. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | Chemotherapy Followed by Avelumab | In chemotherapy phase (CP),based on investigator's decision,participants received either:paclitaxel 175 milligrams per square meter (mg/m2) intravenous (IV) infusion,followed by carboplatin dose at area under curve (AUC) 5 or 6,IV infusion (carboplatin dose (mg) = Target AUC (mg*min/mL) x (glomerular filtration rate[GFR] mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 (1 cycle=21 days). After completion of CP, participants without evidence of disease progression, received avelumab 10 mg/kg, over 1 hour IV infusion,once every 2 weeks on Days 1, 15, and 29 (1 cycle=42 days) in maintenance phase (MP) until confirmed progressive disease,unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Chemotherapy Phase (CP) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 23, 2016 | Sep 5, 2019 |
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| paclitaxel |
| Drug |
Investigator choice of weekly or Q3W during chemotherapy phase |
|
| Avelumab | Drug | Given Q3W in combination with carboplatin/paclitaxel during chemotherapy portion |
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| Avelumab | Drug | Given as single agent in maintenance portion Q2W |
|
| Progression-Free Survival (PFS) as Assessed by Investigator | Investigator assessed PFS was defined as time (in months) from date of randomization to the first documentation of disease progression or death (due to any cause), whichever occurred first. Progression as per RECIST 1.1, was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using a Cox's Proportional Hazard model stratified by the randomization strata and a stratified log-rank test. | Baseline to progression of disease or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months) |
| Percentage of Participants With Objective Response as Assessed by Investigator | Investigator assessed objective response according to RECIST version 1.1, was defined as participants with confirmed best overall response of complete response (CR) or partial response (PR). CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. | Baseline to progression of disease, start of new anti-cancer therapy or discontinuation from study or death, whichever occurred first (maximum duration of 27 months) |
| Percentage of Participants With Objective Response as Assessed by Blinded Independent Central Review (BICR) | BICR assessed objective response according to RECIST version 1.1, was defined as participants with confirmed best overall response of CR or PR. CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. | Baseline to progression of disease, start of new anti-cancer therapy or discontinuation from study or death, whichever occurred first (maximum duration of 27 months) |
| Duration of Response (DOR) as Assessed by Investigator | Investigator assessed DOR: time (in months) from the first documentation of objective response (confirmed CR or PR) to the date of first documentation of PD or death due to any cause. As per RECIST version 1.1, CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. PR: at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method. | First response subsequently confirmed to progression of disease or start of new anti-cancer therapy or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months) |
| Duration of Response (DOR) as Assessed by Blinded Independent Central Review (BICR) | BICR assessed DOR: time (in months) from the first documentation of objective response (confirmed CR or PR) to the date of first documentation of PD or death due to any cause. As per RECIST version 1.1, CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. PR: at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method. | First response subsequently confirmed to progression of disease or start of new anti-cancer therapy or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months) |
| Maintenance Progression-Free Survival as Assessed by Blinded Independent Central Review (BICR) | BICR assessed maintenance PFS was defined as the time from Cycle 1 Day 1 of the maintenance phase to the date of the first documentation of PD or death due to any cause, whichever occurs first. It was defined, for participants who proceeded to maintenance phase and who did not have disease progression by BICR during the chemotherapy phase. As per RECIST version 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method. | From Day 1 of Cycle 1 (42 days) of maintenance phase to progression of disease or death, whichever occurred first (maximum duration of 27 months) |
| Maintenance Progression-Free Survival (PFS) as Assessed by Investigator | Investigator assessed maintenance PFS was defined as the time from Cycle 1 Day 1 of the maintenance phase to the date of the first documentation of PD or death due to any cause, whichever occurs first. It was defined, for participants who proceeded to maintenance phase and who did not have disease progression by investigator during the chemotherapy phase. As per RECIST version 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method | From Day 1 of Cycle 1 (42 days) of maintenance phase to progression of disease or death, whichever occurred first (maximum duration of 27 months) |
| Percentage of Participants With Pathological Complete Response (pCR) | pCR was defined (for neoadjuvant participants who underwent interval debulking surgery [IDS]), as the chemotherapy response score 3 (CSR3), based on a study by Bohm et al, 2015. CSR3 was defined as complete or near-complete response with no residual tumor or minimal irregularly scattered tumor foci seen as individual cells, cell groups, or nodules up to 2 mm. Complete or near-complete response was defined as complete or near-complete microscopic disappearance of invasive tumor/ residual disease. | Baseline to progression of disease or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months) |
| Progression-Free Survival 2 (PFS2) | PFS2 was defined as time (in months) from the date of randomization to the start of second subsequent treatment after first documentation of PD, or death from any cause, whichever occurred first. Progression as per RECIST version 1.1, was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method. | Baseline up to start of second subsequent treatment after first PD or discontinuation from study or death, which ever occured first (maximum duration of 27 months) |
| Progression-Free Survival (PFS) as Assessed by Gynecological Cancer Intergroup (GCIG) Criteria | PFS by GCIG was assessed by both RECIST 1.1 and cancer antigen 125 (CA-125). It was defined as time from randomization to first documentation of disease progression (PD) or death, whichever occurred first. As per RECIST 1.1, PD: greater than or equal to (>=) 20 % increase in the sum of diameters of target lesions, taking as reference the smallest sum on study with absolute increase >= 5 millimeters. PD based on serum CA-125 was defined as (i) participants with elevated CA-125 pretreatment and normalization of CA-125, (ii) participants with CA-125 in the reference range before treatment; (i) and (ii) must have showed CA-125 >= 2 times the upper limit of the reference range on 2 occasions >= 1 week apart, or (iii) participants with elevated CA-125 before treatment, which never normalized, showed CA-125 >= 2 times the nadir value on 2 occasions >= 1 week apart. Censoring date for PFS by GCIG was the latest of the censoring dates for PFS by RECIST 1.1 and PFS by CA-125. | Baseline until disease progression by GCIG criteria or start of new anti-cancer therapy or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months) |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) Graded Based on, National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per NCI-CTCAE version 4.03, Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. Treatment-emergent events are events between first dose of study drug and up to 36 months that were absent before treatment or that worsened relative to pretreatment state. | Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 36 months) |
| Number of Participants With Laboratory Abnormalities Greater Than or Equal to (>=) Grade 3, Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03 | As per NCI-CTCAE v 4.03, Grade 3 and above criteria were; Hematology [Anemia - Grade 3: hemoglobin <8.0 grams per deciliter (g/dL), <4.9 millimoles per liter (mmol/L), <80 grams per liter (g/L), transfusion indicated, Grade 4: life-threatening consequences, urgent intervention indicated, Grade 5: death; platelet count decreased- Grade 3:<50.0 to 25.0*10^9/Liters(L), Grade 4: <25.0*10^9/L; lymphocyte count decreased-Grade 3: <0.5-0.2*10^9/L, Grade 4: <0.2*10^9/L; neutrophil count decreased-Grade 3: <1.0 to 0.5*10^9 /L, Grade 4: <0.5*10^9/L]. Chemistry [creatinine increased-Grade 3: >3.0 to 6.0*upper limit of normal (ULN), Grade 4: >6.0*ULN; serum amylase increased, lipase increased-Grade 3: >2.0 - 5.0*ULN, Grade 4: >5.0*ULN]. Liver function [aspartate aminotransferase (AST) and alanine aminotransferase (ALT)-Grade 3: >5.0 to 20.0*ULN, Grade 4: >20.0*ULN]. | Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 27 months) |
| Change From Baseline in Vital Signs - Blood Pressure at Day 1 of Cycles 2, 3, 4 in Chemotherapy Phase; Days 1, 15 and 29 of Cycles 1 and 2 in Maintenance/ Observation Phase and at End of Treatment | Vital signs included blood pressure and pulse rate. Blood pressure included sitting diastolic blood pressure (DBP) and sitting systolic blood pressure (SBP). MP is applicable only for two arms 'Chemotherapy followed by Avelumab' and 'Chemotherapy + Avelumab followed by Avelumab'. OP is applicable only for third arm 'Chemotherapy followed by Observation'. Category titles 'MP/OP' imply which ever phase was applicable for the respective reporting arms. | Baseline, first 3 months of Chemotherapy Phase (CP): Day 1 of Cycles 2, 3 and 4 (each cycle 21 days); Maintenance/Observation Phase (MP/OP): Days 1, 15 and 29 of Cycles 1 and 2 (each cycle 42 days) and at end of treatment (up to 27 months) |
| Change From Baseline in Vital Signs - Pulse Rate at Day 1 of Cycles 2, 3, 4 in Chemotherapy Phase; Days 1, 15 and 29 of Cycles 1 and 2 in Maintenance/ Observation Phase and at End of Treatment | Vital signs included blood pressure and pulse rate. Changes from baseline in sitting pulse rate were summarized. MP is applicable only for two arms 'Chemotherapy followed by Avelumab' and 'Chemotherapy + Avelumab followed by Avelumab'. OP is applicable only for third arm 'Chemotherapy followed by Observation'. Category titles 'MP/OP' imply which ever phase was applicable for the respective reporting arms. | Baseline, first 3 months of Chemotherapy Phase (CP): Day 1 of Cycles 2, 3 and 4 (each cycle 21 days); Maintenance/Observation Phase (MP/OP): Days 1, 15 and 29 of Cycles 1 and 2 (each cycle 42 days) and at end of treatment (up to 27 months) |
| Number of Participants With Electrocardiogram (ECG) Abnormalities | ECG abnormalities included: 1) QT interval, QT interval corrected using Bazett's formula (QTcB) and QT interval corrected using Fridericia's formula (QTcF): increase from baseline greater than (>) 30 millisecond (ms) or 60 ms; absolute value > 450 ms, >480 ms and > 500 ms; 2) heart rate (HR) : absolute value <=50 bpm and decrease from baseline >=20 bpm; absolute value >=120 beats per minute (bpm) and increase from baseline >=20 bpm; 3) PR interval: absolute value >=220 ms and increase from baseline >=20 ms; 4) QRS interval: absolute value >= 120 ms. | Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 27 months) |
| Functional Assessment of Ovarian Symptom Index- 18 (FOSI-18) Score | National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCN-FACT) Ovarian Symptom Index-18 (FOSI-18) is an 18-itemed participant completed questionnaire, designed to assess impact of cancer therapy on ovarian cancer-related symptoms. Based on numerical point scoring of symptoms. Includes three subscales: disease-related symptoms (10 items), treatment-related side effects (5) and general function/well-being (3). Participants rated their level of symptoms for each items using 5-point scale from 0=not at all to 4=very much. Items that were negatively framed, scores were reversed for analysis so that higher scores= good quality of life. Total symptom index: total of 18 scores, ranging from 0=severely symptomatic to 72=asymptomatic. Higher FOSI-18 scores= better functioning or lower symptom burden. MP applicable only for arms 'Chemotherapy followed by Avelumab' and 'Chemotherapy + Avelumab followed by Avelumab' and OP for 'Chemotherapy followed by Observation'. | CP: Pre-dose on Day 1 of Cycles 2 to 6 (1 cycle= 21 days); MP/OP: Day 1 of Cycles 1 to 12 (1 cycle= 42 days), End of treatment (any time up to Month 27) |
| European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Score | EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). In VAS, participants rated their overall health status from 0 (worst imaginable) to 100 (best imaginable). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Published weights are available that allow for the creation of a single summary score. 57 overall scores ranged from 0 to 1, with low scores representing a higher level of dysfunction. | Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 36 months) |
| Chemotherapy Phase: Maximum Plasma Concentration (Cmax) of Paclitaxel (Once a Week [QW] Regimen) | Cmax is maximum plasma concentration of paclitaxel. The LLQ of paclitaxel was 10.0 ng/mL. | Pre-dose and at 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2 |
| Chemotherapy Phase: Maximum Plasma Concentration (Cmax) of Paclitaxel (Once Every Three Weeks [Q3W] Regimen) | Cmax is maximum plasma concentration of paclitaxel. The LLQ of paclitaxel was 10.0 ng/mL. | Pre-dose and at 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2 |
| Chemotherapy Phase: Maximum Plasma Concentration (Cmax) of Carboplatin (Total and Free) | Cmax is maximum plasma concentration of carboplatin. The LLQ of carboplatin was 100.0 ng/mL. | Pre-dose and at 0.5, 1, 5, 6, 10, and 24 hours post carboplatin infusion on Day 1 of Cycle 2 |
| Chemotherapy Phase: Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUCinf) of Paclitaxel (QW Regimen) | AUCinf is the area under the plasma concentration-time profile from time 0 extrapolated to infinite time. | Pre-dose and at 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2 |
| Chemotherapy Phase: Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUCinf) of Paclitaxel (Q3W Regimen) | AUCinf is the area under the plasma concentration-time profile from time 0 extrapolated to infinite time. | Pre-dose and at 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2 |
| Chemotherapy Phase: Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUCinf) of Carboplatin (Total and Free) | AUCinf is the area under the plasma concentration-time profile from time 0 extrapolated to infinite time. | Pre-dose and at 0.5, 1, 5, 6, 10, and 24 hours post carboplatin infusion on Day 1 of Cycle 2 |
| Chemotherapy Phase: Area Under the Concentration Time Curve From Time Zero to 24 Hours (AUC24) of Paclitaxel (QW Regimen) | AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24). | Pre-dose (0 hour), 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2 |
| Chemotherapy Phase: Area Under the Concentration Time Curve From Time Zero to 24 Hours (AUC24) of Paclitaxel (Q3W Regimen) | AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24). | Pre-dose (0 hour), 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2 |
| Chemotherapy Phase: Area Under the Concentration Time Curve From Time Zero to 24 Hours (AUC24) of Carboplatin (Total and Free) | AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose. | Pre-dose (0 hour), 0.5, 1, 5, 6, 10, and 24 hours post carboplatin infusion on Day 1 of Cycle 2 |
| Maintenance Phase: Predose Plasma Concentration (Ctrough) of Avelumab | Ctrough is the concentration at the end of the dosing interval when avelumab was given as a Q2W regimen in the absence of carboplatin and paclitaxel following 1 cycle of avelumab dosing, i.e. before administration of drug on Day 1 of cycle 2. Ctrough of Avelumab in the absence of chemotherapy (i.e. in the maintenance phase) has been reported. The LLQ of avelumab was 0.20 micro-gram per milliliter (mcg/mL). Data for this outcome measure was not reported for reporting arms "PK: Chemotherapy + Avelumab followed by Avelumab" (since data was not planned to be collected 1 cycle after the initiation of avelumab dosing ) and "PK: Chemotherapy followed by Observation" (since avelumab was not administered in this arm and therefore data collection was not planned). | Pre-dose (0 hour) on Day 1 of Cycle 2 |
| Maintenance Phase: Maximum Plasma Concentration (Cmax) of Avelumab | Cmax is the concentration at the end of a 1 hour infusion, corresponding to the maximum plasma concentration of avelumab. The LLQ of avelumab was 0.20 mcg/mL. Data for this outcome measure was not reported for reporting arms "PK: Chemotherapy + Avelumab followed by Avelumab"(since data was not planned to be collected 1 cycle after the initiation of avelumab dosing ) and "PK: Chemotherapy followed by Observation" (since avelumab was not administered in this arm and therefore data collection was not planned). | End of avelumab infusion on Day 1 of Cycle 2 |
| Chemotherapy Phase: Maximum Plasma Concentration (Cmax) of Avelumab When Given With Paclitaxel and Carboplatin | Cmax is the concentration at the end of a 1 hour infusion, corresponding to the maximum plasma concentration of avelumab. The LLQ of avelumab was 0.20 mcg/mL. Data for this outcome measure was not reported for reporting arms "PK: Chemotherapy followed by Avelumab" (data not available for this OM as avelumab was not given along with paclitaxel and carboplatin in this arm) and "PK: Chemotherapy followed by Observation" (since avelumab was not administered in this arm and therefore data collection was not planned). | End of infusion on Day 1 of Cycle 2 |
| Chemotherapy Phase: Predose Plasma Concentration (Ctrough) of Avelumab When Given With Paclitaxel and Carboplatin | Ctrough is the concentration at the end of the dosing interval when avelumab was given as a Q2W regimen in the absence of carboplatin and paclitaxel following 1 cycle of avelumab dosing, i.e. before administration of drug on Day 1 of cycle 2. The LLQ of avelumab was 0.20 mcg/mL. Data for this outcome measure was not reported for reporting arms "PK: Chemotherapy followed by Avelumab" (data not available for this OM as avelumab was not given along with paclitaxel and carboplatin in this arm) and "PK: Chemotherapy followed by Observation" (since avelumab was not administered in this arm and therefore data collection was not planned). | Pre-dose (0 hour) on Day 1 of Cycle 2 |
| Number of Participants With Anti-Drug Antibodies (ADA) Against Avelumab by Never and Ever Positive Status | ADA against avelumab in serum samples was determined and reported separately for ADA never-positive and ADA ever-positive participants. Participants were considered ADA ever-positive if they had at least one positive (ADA titer greater than or equal to 60 with assay cut point of 1.12) ADA result at any time point during 36 months and were otherwise considered negative. Data for this outcome measure was not planned to be collected and analyzed for reporting arm "Chemotherapy followed by Observation", since, avelumab was not administered in this arm. | Up to 36 months |
| Number of Participants With Neutralizing Antibodies (nAb) Against Avelumab by Never and Ever Positive Status | nAb against avelumab in serum samples was determined and reported separately for nAb never-positive and nAb ever-positive participants. Participants were considered nAb ever-positive if they had at least one positive nAb results (less than or equal to cut point of 0.710 in qualitative competitive ligand binding assay) at any time point during 36 months. nAb never-positive participants were those who had at least one negative nAb results (greater than cut point of 0.710 in qualitative competitive ligand binding assay) at any time point. Data for this outcome measure was not planned to be collected and analyzed for reporting arm "Chemotherapy followed by Observation", since, avelumab was not administered in this arm. | Up to 36 months |
| Number of Participants With Positive Programmed Death Receptor-1 Ligand-1 (PD-L1) Biomarker Expression in Tumor Tissue as Assessed by Immunohistochemistry (IHC) | PD-L1 assessment was performed using immunohistochemistry. Participants were considered positive if their pretreatment tumor tissue sample demonstrated cell surface PD-L1 expression greater than or equal to (>=) 1 percent (%) tumor cells or >= 5% immune cells and were otherwise considered negative. | Up to 36 months |
| Number of Participants With Positive Tumor-Infiltrating Cluster of Differentiation 8 (CD8+) T Lymphocytes Expression in Tumor Tissue as Assessed by Immunohistochemistry (IHC) | CD8 assessment was performed using immunohistochemistry. Participants were considered positive if their pre-treatment tumor tissue sample demonstrated >= 1% CD8 positive cells and were otherwise considered negative. | Up to 36 months |
| Bessemer |
| Alabama |
| 35022 |
| United States |
| Alabama Oncology, Bruno Cancer Center | Birmingham | Alabama | 35205 | United States |
| Alabama Oncology | Birmingham | Alabama | 35209 | United States |
| Alabama Oncology | Birmingham | Alabama | 35211 | United States |
| Alabama Oncology | Birmingham | Alabama | 35235 | United States |
| Alabama Oncology | Birmingham | Alabama | 35243 | United States |
| Arizona Oncology Associates, PC - HAL | Phoenix | Arizona | 85016 | United States |
| Arizona Oncology Associates, PC - HAL | Phoenix | Arizona | 85027 | United States |
| Arizona Oncology Associates, PC - HAL | Scottsdale | Arizona | 85258 | United States |
| Arizona Oncology Associates, PC - HAL | Tempe | Arizona | 85284 | United States |
| Arizona Oncology Associates, PC-HOPE | Tucson | Arizona | 85704 | United States |
| Arizona Oncology Associates, PC-HOPE | Tucson | Arizona | 85711 | United States |
| Highlands Oncology Group | Fayetteville | Arkansas | 72703 | United States |
| Highlands Oncology Group | Rogers | Arkansas | 72758 | United States |
| Oso HomeCare | Irvine | California | 92614 | United States |
| Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute | Los Angeles | California | 90048 | United States |
| Medical Center, Cedars-Sinai | Los Angeles | California | 90048 | United States |
| Gynecologic Oncology Associates | Newport Beach | California | 92663 | United States |
| Chao Family Comprehensive Cancer Center | Orange | California | 92868 | United States |
| Hematology-Oncology Medical Group of Orange County | Orange | California | 92868 | United States |
| Medical Oncology Care Associates | Orange | California | 92868 | United States |
| St. Joseph Hospital of Orange | Orange | California | 92868 | United States |
| The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange | Orange | California | 92868 | United States |
| UC Irvine Health | Orange | California | 92868 | United States |
| University of California, Irvine/UC Irvine Health | Orange | California | 92868 | United States |
| California Pacific Medical Center - Medical Office Building | San Francisco | California | 94109 | United States |
| California Pacific Medical Center - Van Ness Campus | San Francisco | California | 94109 | United States |
| California Pacific Medical Center - Davies Campus | San Francisco | California | 94114 | United States |
| Bryan Hemming Cancer Care Center - California Pacific Medical Center | San Francisco | California | 94115 | United States |
| California Pacific Medical Center - Pacific Heights Outpatient Pharmacy | San Francisco | California | 94115 | United States |
| California Pacific Medical Center-Pacific Campus | San Francisco | California | 94115 | United States |
| California Pacific Medical Center-Research Institute | San Francisco | California | 94115 | United States |
| Palo Alto Medical Foundation Group | San Francisco | California | 94118 | United States |
| Sansum Clinic | Santa Barbara | California | 93105 | United States |
| Sansum Clinic | Solvang | California | 93463 | United States |
| Rocky Mountain Cancer Centers | Aurora | Colorado | 80012 | United States |
| Rocky Mountain Cancer Centers | Boulder | Colorado | 80303 | United States |
| Rocky Mountain Cancer Centers | Lakewood | Colorado | 80228 | United States |
| C/O Thomas Ferencz, RPh, BCOP, Smilow Cancer Hospital at Yale-New Haven | New Haven | Connecticut | 06510 | United States |
| Smilow Cancer Hospital at Yale-New Haven | New Haven | Connecticut | 06510 | United States |
| Smilow Cancer Hospital at Yale-New Haven | New Haven | Connecticut | 06520 | United States |
| Johns Hopkins Sibley Memorial Hospital | Washington D.C. | District of Columbia | 20016 | United States |
| Sibley Memorial Hospital | Washington D.C. | District of Columbia | 20016 | United States |
| UHEALTH Deerfield Beach | Deerfield Beach | Florida | 33442 | United States |
| University of Miami Hospital and Clinics | Miami | Florida | 33136 | United States |
| Orlando Health Gynecological Cancer Center | Orlando | Florida | 32806 | United States |
| Orlando Health UF Health Cancer Center | Orlando | Florida | 32806 | United States |
| Orlando Health, Inc. | Orlando | Florida | 32806 | United States |
| Orlando Health, Inc | Orlando | Florida | 32806 | United States |
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| Investigational Drug Service, Emory University Clinic | Atlanta | Georgia | 30322 | United States |
| The Emory Clinic | Atlanta | Georgia | 30322 | United States |
| Winship Cancer Institute | Atlanta | Georgia | 30322 | United States |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21287 | United States |
| Rcca Md Llc | Bethesda | Maryland | 20817 | United States |
| Rcca Md Llc | Germantown | Maryland | 20874 | United States |
| SKCCC at Johns Hopkins, Green Spring Station | Lutherville | Maryland | 21093 | United States |
| Women's Health Specialists of Montgomery County | Rockville | Maryland | 20852 | United States |
| Holy Cross Resource Center | Silver Spring | Maryland | 20902 | United States |
| Maryland Oncology Hematology | Silver Spring | Maryland | 20904 | United States |
| Holy Cross Hospital, Pharmacy | Silver Spring | Maryland | 20910 | United States |
| Holy Cross Hospital | Silver Spring | Maryland | 20910 | United States |
| Maryland Oncology Hematology | Wheaton | Maryland | 20902 | United States |
| Massachusetts General Hospital Attn: Svetlana Rashkova, RPh | Boston | Massachusetts | 02114 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Beth Israel Deaconess Medical Center Attn: Nisha Sharma | Boston | Massachusetts | 02215 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Dana Farber Cancer Institute Attn: Vasilika Koci, PharmD | Boston | Massachusetts | 02215 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Mercy Ministry Office | Chesterfield | Missouri | 63017 | United States |
| Mercy - Women's Oncology | Springfield | Missouri | 65804 | United States |
| Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center | Springfield | Missouri | 65804 | United States |
| Mercy Hospital Springfield | Springfield | Missouri | 65804 | United States |
| Summit Medical Group | Berkeley Heights | New Jersey | 07922 | United States |
| Summit Medical Group PA | Florham Park | New Jersey | 07932 | United States |
| University Hospital, Investigational Drug Pharmacy | Newark | New Jersey | 07103-6750 | United States |
| University Hospital | Newark | New Jersey | 07103-6750 | United States |
| University Hospital, Ambulatory Care Center | Newark | New Jersey | 07103 | United States |
| University Hospital, The Cancer Center | Newark | New Jersey | 07103 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Medical Arts Radiology | Huntington | New York | 11743 | United States |
| ProHealth Radiology | Huntington | New York | 11743 | United States |
| NYU Winthrop Hospital, Clinical Trials Center | Mineola | New York | 11501 | United States |
| NYU Winthrop Hospital, Gynecologic Oncology | Mineola | New York | 11501 | United States |
| NYU Winthrop Hospital, Infusion Center | Mineola | New York | 11501 | United States |
| NYU Winthrop Hospital, Research Pharmacy | Mineola | New York | 11501 | United States |
| NYU Winthrop Radiology | Mineola | New York | 11501 | United States |
| Montefiore - Einstein Center for Cancer Care | The Bronx | New York | 10461 | United States |
| Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| Montefiore Medical Center, Centennial Women's Center | The Bronx | New York | 10467 | United States |
| Oncology Hematology Care, Inc. | Cincinnati | Ohio | 45211 | United States |
| Oncology Hematology Care, Inc. | Cincinnati | Ohio | 45236 | United States |
| Oncology Hematology Care, Inc. | Cincinnati | Ohio | 45242 | United States |
| Oncology Hematology Care, Inc. | Cincinnati | Ohio | 45245 | United States |
| MetroHealth Medical Center | Cleveland | Ohio | 44106 | United States |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| OSU Wexner Medical Center, Arthur G. James Cancer Hospital & Solove Research Institute | Columbus | Ohio | 43210 | United States |
| OSU Wexner Medical Center, Investigational Drug Services | Columbus | Ohio | 43210 | United States |
| OSU Wexner Medical Center, Stefanie Spielman Comprehensive Breast Center | Columbus | Ohio | 43212 | United States |
| Oncology Hematology Care, Inc. | Fairfield | Ohio | 45014 | United States |
| OSU Wexner Medical Center, Gynecologic Oncology at Mill Run | Hilliard | Ohio | 43026 | United States |
| Willamette Valley Cancer Institute and Research Center | Eugene | Oregon | 97401 | United States |
| Asante Three Rivers Medical Center | Grants Pass | Oregon | 97527 | United States |
| Hematology Oncology Associates | Grants Pass | Oregon | 97527 | United States |
| Asante Pharmacy | Medford | Oregon | 97501 | United States |
| Asante Rogue Regional Medical Center | Medford | Oregon | 97504 | United States |
| Hematology Oncology Associates | Medford | Oregon | 97504 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| Magee-Women's Hospital of UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Pittsburgh Cancer Institute Investigational Drug Service | Pittsburgh | Pennsylvania | 15232 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | United States |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | United States |
| Tennessee Oncology, PLLC | Dickson | Tennessee | 37055 | United States |
| Tennessee Oncology, PLLC | Franklin | Tennessee | 37067 | United States |
| Tennessee Oncology, PLLC | Gallatin | Tennessee | 37066 | United States |
| Tennessee Oncology, PLLC | Hermitage | Tennessee | 37076 | United States |
| Tennessee Oncology, PLLC | Lebanon | Tennessee | 37090 | United States |
| Tennessee Oncology, PLLC | Murfreesboro | Tennessee | 37129 | United States |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37203 | United States |
| The Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37205 | United States |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37207 | United States |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37211 | United States |
| Tennessee Oncology, PLLC | Shelbyville | Tennessee | 37160 | United States |
| Tennessee Oncology, PLLC | Smyrna | Tennessee | 37167 | United States |
| Texas Oncology-Austin Central | Austin | Texas | 78731 | United States |
| Texas Oncology - South Austin | Austin | Texas | 78745 | United States |
| Texas Oncology Bedford | Bedford | Texas | 76022 | United States |
| Parkland Health and Hospital System | Dallas | Texas | 75235 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| UT Southwestern Medical Center-Clements University Hospital | Dallas | Texas | 75390 | United States |
| UT Southwestern Medical Center-Zale Lipshy University Hospital | Dallas | Texas | 75390 | United States |
| Texas Oncology - Fort Worth Cancer Center | Fort Worth | Texas | 76104 | United States |
| US Oncology Investigational Products Center (IPC) | Irving | Texas | 75063 | United States |
| US Oncology Investigational Products Center | Irving | Texas | 75063 | United States |
| Texas Oncology - San Antonio Medical Center | San Antonio | Texas | 78240 | United States |
| Utah Cancer Specialists | Layton | Utah | 84041 | United States |
| Utah Cancer Specialists | Murray | Utah | 84157 | United States |
| Utah Cancer Specialists | Salt Lake City | Utah | 84102 | United States |
| Utah Cancer Specialists | Salt Lake City | Utah | 84106 | United States |
| Utah Cancer Specialists | West Jordan | Utah | 84088 | United States |
| Emily Couric Cancer Center | Charlottesville | Virginia | 22903 | United States |
| MHAT for Female Health-Nadezhda OOD | Sofia | 1373 | Bulgaria |
| Shato Ead | Sofia | 1756 | Bulgaria |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| Juravinski Cancer Centre | Hamilton | Ontario | L8V 5C2 | Canada |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
| McGill University Health Centre-Glen Site | Montreal | Quebec | H4A 3J1 | Canada |
| Oncology Pharmacy McGill University Health Centre | Montreal | Quebec | H4A 3J1 | Canada |
| CHU de Quebec-Universite Laval | Québec | Quebec | G1R 2J6 | Canada |
| Klinicki bolnicki centar Split | Split | 21000 | Croatia |
| Klinicki bolnicki centar Sestre milosrdnice | Zagreb | 10000 | Croatia |
| East Tallinn Central Hospital | Tallinn | 10138 | Estonia |
| East-Tallinn Central Hospital, Center of Oncology | Tallinn | 11312 | Estonia |
| North Estonia Medical Centre Foundation, Pharmacy | Tallinn | 13419 | Estonia |
| North Estonia Medical Centre Foundation | Tallinn | 13419 | Estonia |
| Tartu University Hospital, Hematology and Oncology Clinic | Tartu | 51014 | Estonia |
| Zentralapotheke Zytostatika | Chemnitz | 09113 | Germany |
| Klinikum Chemnitz gGmbH | Chemnitz | 09116 | Germany |
| Radiologie Uniklinik Koeln | Cologne | 50931 | Germany |
| Uniklinik Koeln Apotheke | Cologne | 50931 | Germany |
| Uniklinik Koeln Klinik fuer Frauenheilkunde und Geburtshilfe | Cologne | 50931 | Germany |
| Johannes Apotheke Klinikversorgung | Gröbenzell | 82194 | Germany |
| Radiologie Muenchen | München | 80634 | Germany |
| Frauenklinik am Rotkreuzklinikum Muenchen | München | 80637 | Germany |
| Diagnostische und Interventionelle Radiologie | Potsdam | 14467 | Germany |
| Klinikum Ernst von Bergmann gGmbH | Potsdam | 14467 | Germany |
| Universitaetsklinikum Wuerzburg Frauenklinik und Poliklinik | Würzburg | 97080 | Germany |
| Queen Elizabeth Hospital | Hong Kong | Hong Kong |
| The University of Hong Kong | Hong Kong | Hong Kong |
| Semmelweis Egyetem Onkologiai Kozpont | Budapest | 1083 | Hungary |
| Debreceni Egyetem Klinikai Gyogyszertar | Debrecen | 4032 | Hungary |
| Debreceni Egyetem Klinikai Kozpont, Szuleszeti es Nogyogyaszati Klinika | Debrecen | 4032 | Hungary |
| Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet, Onkologiai Kozpont | Szolnok | 5000 | Hungary |
| Mater Misericordiae University Hospital | Dublin | Dublin | 7 | Ireland |
| Mater Private Hospital | Dublin | Dublin | Dublin 7 | Ireland |
| Bon Secours Hospital Ireland | Cork | Ireland |
| Bon Secours Hospital | Cork | Ireland |
| Pharmacy Department, St James's Hospital | Dublin | 8 | Ireland |
| Mater Misericordiae University Hospital | Dublin | D7 | Ireland |
| Mater Private Hospital | Dublin | D7 | Ireland |
| St James's Hospital | Dublin | Ireland |
| Azienda Ospedaliero -Universitaria di Bologna Policlinico S. Orsola - Malpighi | Bologna | BO | 40138 | Italy |
| Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola - Malpighi | Bologna | BO | 40138 | Italy |
| E.O. Ospedali Galliera | Genova | GE | 16128 | Italy |
| Farmacia Galliera | Genova | GE | 16128 | Italy |
| Istituto Europeo di Oncologia | Milan | MI | 20141 | Italy |
| ASST Grande Ospedale Metropolitano Niguarda | Milan | MI | 20162 | Italy |
| Azienda Socio Sanitaria Territoriale ASST della Valtellina e dell Alto Lario | Sondrio | SO | 23100 | Italy |
| Istituto Nazionale Tumori Napoli IRCCS Fondazione Pascale | Naples | 80131 | Italy |
| Dip.to per la Tutela della Salute della Donna, della Vita Nascente, del Bambino e dell'Adolescente | Roma | 00168 | Italy |
| The Jikei University Kashiwa Hospital | Kashiwa-shi | Chiba | 277-8567 | Japan |
| Shikoku Cancer Center | Matsuyama | Ehime | 791-0280 | Japan |
| Ehime University Hospital | Tōon | Ehime | 791-0295 | Japan |
| Kurume University Hospital | Kurume | Fukuoka | 830-0011 | Japan |
| Hokkaido University Hospital | Sapporo | Hokkaido | 060-8648 | Japan |
| Hyogo Cancer Center | Akashi | Hyōgo | 673-8558 | Japan |
| University of Tsukuba Hospital | Tsukuba | Ibaraki | 305-8576 | Japan |
| Tokai University Hospital | Isehara | Kanagawa | 259-1193 | Japan |
| Kyoto University Hospital | Sakyo-ku | Kyoto | 606-8507 | Japan |
| Tohoku University Hospital | Sendai | Miyagi | 980-8574 | Japan |
| Saitama Medical University International Medical Center | Hidaka | Saitama | 350-1298 | Japan |
| National Defense Medical College Hospital | Tokorozawa | Saitama | 359-8513 | Japan |
| Shizuoka Cancer Center | Sunto-gun | Shizuoka | 411-8777 | Japan |
| National Cancer Center Hospital | Chuo-ku | Tokyo | 104-0045 | Japan |
| The Jikei University Hospital | Minato-ku | Tokyo | 105-8471 | Japan |
| Niigata Cancer Center Hospital | Niigata | 951-8566 | Japan |
| Daugavpils Regional Hospital, Oncology Department (11 floor) | Daugavpils | LV5417 | Latvia |
| Daugavpils Regional Hospital | Daugavpils | LV5417 | Latvia |
| Natalja Goncarova -Radiology Services | Daugavpils | LV5417 | Latvia |
| Inga Vigule-Radiology services | Liepāja | LV-3414 | Latvia |
| Liepaja Regional hospital | Liepāja | LV3414 | Latvia |
| Pauls Stradins Clinical University Hospital | Riga | LV 1002 | Latvia |
| Medical Society "ARS" Ltd | Riga | LV-1010 | Latvia |
| Instituto Nacional de Cancerologia | Mexico City | Mexico City | 14080 | Mexico |
| Hospital Universitario Dr. Jose Eleuterio Gonzalez | Monterrey | Nuevo León | 64460 | Mexico |
| Academisch Medisch Centrum | Amsterdam | 1105 AZ | Netherlands |
| Pharmacy Universitair Medisch Centrum Groningen | Groningen | 9713 AP | Netherlands |
| Universitair Medisch Centrum Groningen | Groningen | 9713 GZ | Netherlands |
| LUMC | Leiden | 2333 ZA | Netherlands |
| Maastricht Universitair Medisch Centrum | Maastricht | 6229 HX | Netherlands |
| Pharmacy Zuyderland Medisch Centrum | Sittard-Geleen | 6162 AP | Netherlands |
| Zuyderland Medisch Centrum | Sittard-Geleen | 6162 BG | Netherlands |
| Szpitale Pomorskie Sp. z.o.o., Apteka Szpitalna | Gdynia | 81-519 | Poland |
| Szpitale Pomorskie, Sp. z o. o., Oddzial Onkologii i Radioterapii | Gdynia | 81-519 | Poland |
| Centrum Onkologii, Instytut im. M. Sklodowskiej-Curie, Oddzial w Krakowie, Apteka Szpitalna | Krakow | 31-115 | Poland |
| Centrum Onkologii, Instytut im.M.Sklodowskiej-Curie, Oddzial w Krakowie | Krakow | 31-115 | Poland |
| Wojewodzki Szpital Specjalistyczny w Olsztynie. Apteka Szpitalna | Olsztyn | 10-561 | Poland |
| Wojewodzki Szpital Specjalistyczny w Olsztynie | Olsztyn | 10-561 | Poland |
| Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu | Opole | 45-061 | Poland |
| Ginekologiczno - Polozniczy Szpital Kliniczny Uniwersytetu Medycznego im. Karola Marcinkowskiego w | Poznan | 60-535 | Poland |
| SC Medisprof SRL | Cluj-Napoca | Cluj | 400641 | Romania |
| SC Oncolab SRL | Craiova | Dolj | 200385 | Romania |
| SC Centrul de Oncologie Euroclinic SRL | Iași | 700106 | Romania |
| Limited liability company (LLC) EVIMED | Chelyabinsk | Chelyabinsk Oblast | 454048 | Russia |
| State Budgetary Healthcare Institution | Chelyabinsk | Chelyabinsk Oblast | 454087 | Russia |
| Regional Budgetary Healthcare Institution (RBHI) Ivanovo Regional Oncology Dispensary | Ivanovo | Ivanovo Oblast | 153040 | Russia |
| FSBI - NMRRC Minzdrav Russia at the branch A.F.Tsyb Medical Radiological Research Centre | Obninsk | Kaluga Oblast | 249036 | Russia |
| SBHI Orenburg Regional Clinical Oncology Dispensary (SBHI ORCOD) | Orenburg | Orenburg Oblast | 460021 | Russia |
| SAHI "Republican Clinical Oncology Dispensary of the MoH of TR" | Kazan' | Tatarstan Republic | 420029 | Russia |
| SBHI Moscow Clinical Scientific and Practical Centre of Moscow City Healthcare Department | Moscow | 111123 | Russia |
| FSBI National Research Medical Center of Oncology N.A. | Moscow | 115478 | Russia |
| Clinic | Moscow | 121309 | Russia |
| Limited liability company VitaMed-LLC VitaMed | Moscow | 129515 | Russia |
| SBHI Saint-Petersburg Clinical Scientific - Practice Center of Specialized Types of Medical Care | Saint Petersburg | 197758 | Russia |
| National University Hospital | Singapore | 119074 | Singapore |
| National University Hospital, Pharmacy @ NCIS | Singapore | 119082 | Singapore |
| Raffles Hospital | Singapore | 188770 | Singapore |
| NsP sv. Jakuba, n.o. , Bardejov | Bardejov | 08501 | Slovakia |
| Onkologicky ustav sv. Alzbety a.s. | Bratislava | 81250 | Slovakia |
| Narodny onkologicky ustav | Bratislava | 83310 | Slovakia |
| Vychodoslovensky onkologicky ustav, a.s. | Košice | 04191 | Slovakia |
| POKO Poprad s.r.o. | Poprad | 05801 | Slovakia |
| Center for Uterine Cancer, National Cancer Center | Goyang-si | Gyeonggi-do | 10408 | South Korea |
| Clinical Trial Pharmacy, National Cancer Center | Goyang-si | Gyeonggi-do | 10408 | South Korea |
| CHA Bundang Medical Center, CHA University, Clinical Trial Pharmacy | Seongnam-si | Gyeonggi-do | 13496 | South Korea |
| CHA Bundang Medical Center, CHA University | Seongnam-si | Gyeonggi-do | 13496 | South Korea |
| Korea University Anam Hospital, Clinical Trial Pharmacy | Seoul | 02841 | South Korea |
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
| CTC Cancer Pharmacy, Seoul National University Hospital | Seoul | 03080 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center, Clinical Research Pharmacy | Seoul | 05505 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Clinical Trial Pharmacy, Samsung Medical Center | Seoul | 06351 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Clinical Trial Pharmacy, Korea University Guro Hospital | Seoul | 08308 | South Korea |
| Korea University Guro Hospital | Seoul | 08308 | South Korea |
| Kantonsspital Winterthur | Winterthur | Canton of Zurich | 8401 | Switzerland |
| Oncology Institute of Southern Switzerland (IOSI) | Bellinzona | Canton Ticino | 6500 | Switzerland |
| Ospedale San Giovanni | Bellinzona | Canton Ticino | 6500 | Switzerland |
| Radiologia ORBV | Bellinzona | Canton Ticino | 6500 | Switzerland |
| Taichung Veterans General Hospital | Taichung | 407 | Taiwan |
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| Clinical Trial Pharmacy, MacKay Memorial Hospital | Taipei | 10449 | Taiwan |
| Mackay Memorial Hospital | Taipei | 104 | Taiwan |
| Cathay General Hospital | Taipei | 106 | Taiwan |
| Clinical Trial Pharmacy, Koo Foundation Sun Yat-Sen Cancer Center | Taipei | 112 | Taiwan |
| Clinical Trial Pharmacy, Taipei Veterans General Hospital | Taipei | 112 | Taiwan |
| Koo Foundation Sun Yat-Sen Cancer Center | Taipei | 112 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 112 | Taiwan |
| Chang Gung Memorial Hospital - Linkou Branch | Taoyuan City | 333 | Taiwan |
| Chemotherapy Pharmacy, Chang Gung Memorial Hospital - Linkou Branch | Taoyuan City | 333 | Taiwan |
| Baskent University Adana Training and Research Hospital | Adana | 01120 | Turkey (Türkiye) |
| Baskent University Ankara Hospital, Department of Oncology | Ankara | 06490 | Turkey (Türkiye) |
| Bezmialem Vakif University Medical Faculty Hospital | Istanbul | 34093 | Turkey (Türkiye) |
| Istanbul University Oncology Institute | Istanbul | 34093 | Turkey (Türkiye) |
| Istanbul University Cerrahpasa-Cerrahpasa Medical Faculty | Istanbul | 34098 | Turkey (Türkiye) |
| Ege University Faculty of Medicine Hospital | Izmir | 35100 | Turkey (Türkiye) |
| Communal Institution Chernivtsi Regional Clinical Oncology Dispensary | Chernivtsi | 58013 | Ukraine |
| Cl Dnipropetrovsk City Multifield Clinical Hospital | Dnipropetrovsk | 49102 | Ukraine |
| Municipal Institution Kryviy Rih Oncology Center of Dnipropetrovsk regional Council | Kryviy Rig | 50048 | Ukraine |
| Clinic of National Cancer Institute | Kyiv | 03022 | Ukraine |
| CNE of Lviv Regional Council "Lviv Oncological Regional Therapeutical and Diagnostic Centre" | Lviv | 79031 | Ukraine |
| Central Municipal Clinical Hospital, Municipal oncology center, therapeutics department | Uzhhorod | 88000 | Ukraine |
| Torbay and South Devon NHS Foundation Trust | Torquay | Devon | TQ2 7AA | United Kingdom |
| East Kent Hospitals University NHS Foundation Trust | Margate | KENT | CT9 4AN | United Kingdom |
| University College London Hospital NHS Foundation Trust | Islington | London | N79NH | United Kingdom |
| The Clatterbridge Cancer Centre NHS Foundation Trust | Bebington, Wirral | Merseyside | CH63 4JY | United Kingdom |
| The Clatterbridge Cancer Centre NHS Foundation Trust | Metropolitan Borough of Wirral | Merseyside | CH63 4JY | United Kingdom |
| East and North Hertfordshire NHS Trust | Northwood | Middlesex | HA6 2RN | United Kingdom |
| Oxford University Hospitals NHS Foundation Trust | Headington | Oxford | OX3 7LE | United Kingdom |
| Royal Surrey County Hospital NHS Foundation Trust | Guildford | Surrey | GU2 7XX | United Kingdom |
| Royal Marsden NHS Foundation Trust | Sutton | Surrey | SM2 5PT | United Kingdom |
| The Royal Marsden NHS Foundation Trust | Sutton | Surrey | SM2 5PT | United Kingdom |
| University Hospitals Bristol NHS Foundation trust | Bristol | BS2 8ED | United Kingdom |
| Cambridge University Hospitals NHS Foundation Trust | Cambridge | CB2 0QQ | United Kingdom |
| University College London Hospital NHS Foundation Trust | London | NW1 2BU | United Kingdom |
| University College London Hospital NHS Foundation Trust | London | NW1 2PG | United Kingdom |
| Guy's & St Thomas' NHS Foundation Trust | London | SE1 9RT | United Kingdom |
| Royal Marsden NHS Foundation Trust | London | SW3 6JJ | United Kingdom |
| Imperial College Healthcare NHS Trust | London | W12 0HS | United Kingdom |
| University College London Hospital | London | WC1E 6AG | United Kingdom |
| The Christie Hospital NHS Foundation Trust | Manchester | M20 4BX | United Kingdom |
| Baxter Healthcare | Stockport | SK4 5GA | United Kingdom |
| FG001 | Chemotherapy + Avelumab Followed by Avelumab | In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months. |
| FG002 | Chemotherapy Followed by Observation | In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months. |
| Safety Population | Participants who had received at least one dose of study drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Maintenance Phase (MP) |
|
|
| Observation Phase (OP) |
|
|
| Follow-up Phase |
|
|
| Long-term Follow-up Phase |
|
|
The full analysis set included all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Chemotherapy Followed by Avelumab | In chemotherapy phase (CP),based on investigator's decision,participants received either:paclitaxel 175 milligrams per square meter (mg/m2) intravenous (IV) infusion,followed by carboplatin dose at area under curve (AUC) 5 or 6,IV infusion (carboplatin dose (mg) = Target AUC (mg*min/mL) x (glomerular filtration rate[GFR] mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 (1 cycle=21 days). After completion of CP, participants without evidence of disease progression, received avelumab 10 mg/kg, over 1 hour IV infusion,once every 2 weeks on Days 1, 15, and 29 (1 cycle=42 days) in maintenance phase (MP) until confirmed progressive disease,unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months. |
| BG001 | Chemotherapy + Avelumab Followed by Avelumab | In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months. |
| BG002 | Chemotherapy Followed by Observation | In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months. |
| BG003 | Total | Total of all reporting groups |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) | BICR assessed PFS: Duration from randomization until disease progression or death. PFS data was censored on the date of the last adequate tumor assessment for participants who did not have an event (progression of disease or death), who started a new anti-cancer therapy prior to an event or for participants with an event after 2 or more missing tumor assessments. Progression as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1: as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method. | The full analysis set included all randomized participants. | Posted | Median | 95% Confidence Interval | months | Baseline to progression of disease or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months) |
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| Secondary | Overall Survival | Overall survival was defined as the time (in months) from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method. | The full analysis set included all randomized participants. | Posted | Median | 95% Confidence Interval | months | Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 27 months) |
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| Secondary | Progression-Free Survival (PFS) as Assessed by Investigator | Investigator assessed PFS was defined as time (in months) from date of randomization to the first documentation of disease progression or death (due to any cause), whichever occurred first. Progression as per RECIST 1.1, was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using a Cox's Proportional Hazard model stratified by the randomization strata and a stratified log-rank test. | The full analysis set included all randomized participants. | Posted | Median | 95% Confidence Interval | months | Baseline to progression of disease or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months) |
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| Secondary | Percentage of Participants With Objective Response as Assessed by Investigator | Investigator assessed objective response according to RECIST version 1.1, was defined as participants with confirmed best overall response of complete response (CR) or partial response (PR). CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. | The full analysis set included all randomized participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline to progression of disease, start of new anti-cancer therapy or discontinuation from study or death, whichever occurred first (maximum duration of 27 months) |
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| Secondary | Percentage of Participants With Objective Response as Assessed by Blinded Independent Central Review (BICR) | BICR assessed objective response according to RECIST version 1.1, was defined as participants with confirmed best overall response of CR or PR. CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. | The full analysis set included all randomized participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline to progression of disease, start of new anti-cancer therapy or discontinuation from study or death, whichever occurred first (maximum duration of 27 months) |
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| Secondary | Duration of Response (DOR) as Assessed by Investigator | Investigator assessed DOR: time (in months) from the first documentation of objective response (confirmed CR or PR) to the date of first documentation of PD or death due to any cause. As per RECIST version 1.1, CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. PR: at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method. | Analysis was performed on subset of randomized participants, who had objective response, as assessed by Investigator. | Posted | Median | 95% Confidence Interval | months | First response subsequently confirmed to progression of disease or start of new anti-cancer therapy or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months) |
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| Secondary | Duration of Response (DOR) as Assessed by Blinded Independent Central Review (BICR) | BICR assessed DOR: time (in months) from the first documentation of objective response (confirmed CR or PR) to the date of first documentation of PD or death due to any cause. As per RECIST version 1.1, CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. PR: at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method. | Analysis was performed on subset of randomized participants, who had objective response, as assessed by BICR. | Posted | Median | 95% Confidence Interval | months | First response subsequently confirmed to progression of disease or start of new anti-cancer therapy or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months) |
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| Secondary | Maintenance Progression-Free Survival as Assessed by Blinded Independent Central Review (BICR) | BICR assessed maintenance PFS was defined as the time from Cycle 1 Day 1 of the maintenance phase to the date of the first documentation of PD or death due to any cause, whichever occurs first. It was defined, for participants who proceeded to maintenance phase and who did not have disease progression by BICR during the chemotherapy phase. As per RECIST version 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method. | The analysis set included randomized participants who proceeded to maintenance phase and who did not have PD by BICR assessment during the chemotherapy phase. | Posted | Median | 95% Confidence Interval | months | From Day 1 of Cycle 1 (42 days) of maintenance phase to progression of disease or death, whichever occurred first (maximum duration of 27 months) |
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| Secondary | Maintenance Progression-Free Survival (PFS) as Assessed by Investigator | Investigator assessed maintenance PFS was defined as the time from Cycle 1 Day 1 of the maintenance phase to the date of the first documentation of PD or death due to any cause, whichever occurs first. It was defined, for participants who proceeded to maintenance phase and who did not have disease progression by investigator during the chemotherapy phase. As per RECIST version 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method | The analysis set included randomized participants who proceeded to maintenance phase and who did not have PD by investigator assessment during the chemotherapy phase. | Posted | Median | 95% Confidence Interval | months | From Day 1 of Cycle 1 (42 days) of maintenance phase to progression of disease or death, whichever occurred first (maximum duration of 27 months) |
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| Secondary | Percentage of Participants With Pathological Complete Response (pCR) | pCR was defined (for neoadjuvant participants who underwent interval debulking surgery [IDS]), as the chemotherapy response score 3 (CSR3), based on a study by Bohm et al, 2015. CSR3 was defined as complete or near-complete response with no residual tumor or minimal irregularly scattered tumor foci seen as individual cells, cell groups, or nodules up to 2 mm. Complete or near-complete response was defined as complete or near-complete microscopic disappearance of invasive tumor/ residual disease. | Analysis was performed on a subset of randomized participants which included neoadjuvant participants who underwent IDS. | Posted | Number | percentage of participants | Baseline to progression of disease or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months) |
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| Secondary | Progression-Free Survival 2 (PFS2) | PFS2 was defined as time (in months) from the date of randomization to the start of second subsequent treatment after first documentation of PD, or death from any cause, whichever occurred first. Progression as per RECIST version 1.1, was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method. | The trial was terminated due to crossing of futility boundaries for both experimental arms as compared to the control arm at the pre-specified interim analysis for PFS based on BICR assessment. Subsequently, the data for this outcome measure was not collected and analyzed. | Posted | Baseline up to start of second subsequent treatment after first PD or discontinuation from study or death, which ever occured first (maximum duration of 27 months) |
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| Secondary | Progression-Free Survival (PFS) as Assessed by Gynecological Cancer Intergroup (GCIG) Criteria | PFS by GCIG was assessed by both RECIST 1.1 and cancer antigen 125 (CA-125). It was defined as time from randomization to first documentation of disease progression (PD) or death, whichever occurred first. As per RECIST 1.1, PD: greater than or equal to (>=) 20 % increase in the sum of diameters of target lesions, taking as reference the smallest sum on study with absolute increase >= 5 millimeters. PD based on serum CA-125 was defined as (i) participants with elevated CA-125 pretreatment and normalization of CA-125, (ii) participants with CA-125 in the reference range before treatment; (i) and (ii) must have showed CA-125 >= 2 times the upper limit of the reference range on 2 occasions >= 1 week apart, or (iii) participants with elevated CA-125 before treatment, which never normalized, showed CA-125 >= 2 times the nadir value on 2 occasions >= 1 week apart. Censoring date for PFS by GCIG was the latest of the censoring dates for PFS by RECIST 1.1 and PFS by CA-125. | The trial was terminated due to crossing of futility boundaries for both experimental arms as compared to the control arm at the pre-specified interim analysis for PFS based on BICR assessment. Subsequently, the data for this outcome measure was not collected and analyzed. | Posted | Baseline until disease progression by GCIG criteria or start of new anti-cancer therapy or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months) |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (AEs) Graded Based on, National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per NCI-CTCAE version 4.03, Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. Treatment-emergent events are events between first dose of study drug and up to 36 months that were absent before treatment or that worsened relative to pretreatment state. | The safety analysis set included all participants who had received at least one dose of study drug. Here "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 36 months) |
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| Secondary | Number of Participants With Laboratory Abnormalities Greater Than or Equal to (>=) Grade 3, Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03 | As per NCI-CTCAE v 4.03, Grade 3 and above criteria were; Hematology [Anemia - Grade 3: hemoglobin <8.0 grams per deciliter (g/dL), <4.9 millimoles per liter (mmol/L), <80 grams per liter (g/L), transfusion indicated, Grade 4: life-threatening consequences, urgent intervention indicated, Grade 5: death; platelet count decreased- Grade 3:<50.0 to 25.0*10^9/Liters(L), Grade 4: <25.0*10^9/L; lymphocyte count decreased-Grade 3: <0.5-0.2*10^9/L, Grade 4: <0.2*10^9/L; neutrophil count decreased-Grade 3: <1.0 to 0.5*10^9 /L, Grade 4: <0.5*10^9/L]. Chemistry [creatinine increased-Grade 3: >3.0 to 6.0*upper limit of normal (ULN), Grade 4: >6.0*ULN; serum amylase increased, lipase increased-Grade 3: >2.0 - 5.0*ULN, Grade 4: >5.0*ULN]. Liver function [aspartate aminotransferase (AST) and alanine aminotransferase (ALT)-Grade 3: >5.0 to 20.0*ULN, Grade 4: >20.0*ULN]. | The safety analysis set included all participants who received at least one dose of study drug. Here, 'Number analyzed' = Participants evaluable for this outcome measure for each specified row. | Posted | Count of Participants | Participants | Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 27 months) |
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| Secondary | Change From Baseline in Vital Signs - Blood Pressure at Day 1 of Cycles 2, 3, 4 in Chemotherapy Phase; Days 1, 15 and 29 of Cycles 1 and 2 in Maintenance/ Observation Phase and at End of Treatment | Vital signs included blood pressure and pulse rate. Blood pressure included sitting diastolic blood pressure (DBP) and sitting systolic blood pressure (SBP). MP is applicable only for two arms 'Chemotherapy followed by Avelumab' and 'Chemotherapy + Avelumab followed by Avelumab'. OP is applicable only for third arm 'Chemotherapy followed by Observation'. Category titles 'MP/OP' imply which ever phase was applicable for the respective reporting arms. | The safety analysis set included all participants who had received at least one dose of study drug. Here "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and 'Number analyzed' = participants evaluable for this outcome measure at specified rows. | Posted | Mean | Standard Deviation | millimeters of mercury | Baseline, first 3 months of Chemotherapy Phase (CP): Day 1 of Cycles 2, 3 and 4 (each cycle 21 days); Maintenance/Observation Phase (MP/OP): Days 1, 15 and 29 of Cycles 1 and 2 (each cycle 42 days) and at end of treatment (up to 27 months) |
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| Secondary | Change From Baseline in Vital Signs - Pulse Rate at Day 1 of Cycles 2, 3, 4 in Chemotherapy Phase; Days 1, 15 and 29 of Cycles 1 and 2 in Maintenance/ Observation Phase and at End of Treatment | Vital signs included blood pressure and pulse rate. Changes from baseline in sitting pulse rate were summarized. MP is applicable only for two arms 'Chemotherapy followed by Avelumab' and 'Chemotherapy + Avelumab followed by Avelumab'. OP is applicable only for third arm 'Chemotherapy followed by Observation'. Category titles 'MP/OP' imply which ever phase was applicable for the respective reporting arms. | The safety analysis set included all participants who had received at least one dose of study drug. Here "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and 'Number analyzed' = participants evaluable for this outcome measure at specified rows. | Posted | Mean | Standard Deviation | beats per minute | Baseline, first 3 months of Chemotherapy Phase (CP): Day 1 of Cycles 2, 3 and 4 (each cycle 21 days); Maintenance/Observation Phase (MP/OP): Days 1, 15 and 29 of Cycles 1 and 2 (each cycle 42 days) and at end of treatment (up to 27 months) |
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| Secondary | Number of Participants With Electrocardiogram (ECG) Abnormalities | ECG abnormalities included: 1) QT interval, QT interval corrected using Bazett's formula (QTcB) and QT interval corrected using Fridericia's formula (QTcF): increase from baseline greater than (>) 30 millisecond (ms) or 60 ms; absolute value > 450 ms, >480 ms and > 500 ms; 2) heart rate (HR) : absolute value <=50 bpm and decrease from baseline >=20 bpm; absolute value >=120 beats per minute (bpm) and increase from baseline >=20 bpm; 3) PR interval: absolute value >=220 ms and increase from baseline >=20 ms; 4) QRS interval: absolute value >= 120 ms. | The safety analysis set included all participants who had received at least one dose of study drug. Here "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and 'Number analyzed' = participants in the safety analysis set who had at least one baseline and post-baseline ECG assessment. | Posted | Count of Participants | Participants | Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 27 months) |
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| Secondary | Functional Assessment of Ovarian Symptom Index- 18 (FOSI-18) Score | National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCN-FACT) Ovarian Symptom Index-18 (FOSI-18) is an 18-itemed participant completed questionnaire, designed to assess impact of cancer therapy on ovarian cancer-related symptoms. Based on numerical point scoring of symptoms. Includes three subscales: disease-related symptoms (10 items), treatment-related side effects (5) and general function/well-being (3). Participants rated their level of symptoms for each items using 5-point scale from 0=not at all to 4=very much. Items that were negatively framed, scores were reversed for analysis so that higher scores= good quality of life. Total symptom index: total of 18 scores, ranging from 0=severely symptomatic to 72=asymptomatic. Higher FOSI-18 scores= better functioning or lower symptom burden. MP applicable only for arms 'Chemotherapy followed by Avelumab' and 'Chemotherapy + Avelumab followed by Avelumab' and OP for 'Chemotherapy followed by Observation'. | The full analysis set included all randomized participants. Here, 'Number analyzed' = participants evaluable for this outcome measure at specified rows. Category titles 'MP/OP' imply which ever phase was applicable for the respective reporting arms. | Posted | Mean | 95% Confidence Interval | units on a scale | CP: Pre-dose on Day 1 of Cycles 2 to 6 (1 cycle= 21 days); MP/OP: Day 1 of Cycles 1 to 12 (1 cycle= 42 days), End of treatment (any time up to Month 27) |
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| Secondary | European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Score | EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). In VAS, participants rated their overall health status from 0 (worst imaginable) to 100 (best imaginable). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Published weights are available that allow for the creation of a single summary score. 57 overall scores ranged from 0 to 1, with low scores representing a higher level of dysfunction. | The trial was terminated due to crossing of futility boundaries for both experimental arms as compared to the control arm at the pre-specified interim analysis for PFS based on BICR assessment. Subsequently, the data for this outcome measure was not collected and analyzed. | Posted | Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 36 months) |
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| Secondary | Chemotherapy Phase: Maximum Plasma Concentration (Cmax) of Paclitaxel (Once a Week [QW] Regimen) | Cmax is maximum plasma concentration of paclitaxel. The LLQ of paclitaxel was 10.0 ng/mL. | Paclitaxel PK parameter analysis set: all participants who received at least one dose of study drug and who had at least one of the PK parameters of interest for paclitaxel. Here "Overall number of participants analyzed" signifies participants who received Paclitaxel infusion on QW regimen and had data available for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose and at 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2 |
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| Secondary | Chemotherapy Phase: Maximum Plasma Concentration (Cmax) of Paclitaxel (Once Every Three Weeks [Q3W] Regimen) | Cmax is maximum plasma concentration of paclitaxel. The LLQ of paclitaxel was 10.0 ng/mL. | Paclitaxel PK parameter analysis set: all participants who had received at least one dose of study drug and who had at least one of the PK parameters of interest for paclitaxel. Here "Overall number of participants analyzed" signifies participants who received Paclitaxel infusion on Q3W regimen and had data available for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose and at 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2 |
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| Secondary | Chemotherapy Phase: Maximum Plasma Concentration (Cmax) of Carboplatin (Total and Free) | Cmax is maximum plasma concentration of carboplatin. The LLQ of carboplatin was 100.0 ng/mL. | Carboplatin PK parameter analysis set included all participants who had received at least one dose of study drug and who had at least one of the PK parameters of interest for carboplatin. Here "Overall number of participants analyzed" signifies participants who had data available for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose and at 0.5, 1, 5, 6, 10, and 24 hours post carboplatin infusion on Day 1 of Cycle 2 |
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| Secondary | Chemotherapy Phase: Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUCinf) of Paclitaxel (QW Regimen) | AUCinf is the area under the plasma concentration-time profile from time 0 extrapolated to infinite time. | Paclitaxel PK parameter analysis set: all participants who received at least one dose of study drug and who had at least one of the PK parameters of interest for paclitaxel. Here "Overall number of participants analyzed" signifies participants who received Paclitaxel infusion on QW regimen and had data available for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | Pre-dose and at 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2 |
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| Secondary | Chemotherapy Phase: Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUCinf) of Paclitaxel (Q3W Regimen) | AUCinf is the area under the plasma concentration-time profile from time 0 extrapolated to infinite time. | Paclitaxel PK parameter analysis set: all participants who had received at least one dose of study drug and who had at least one of the PK parameters of interest for paclitaxel. Here "Overall number of participants analyzed" signifies participants who received Paclitaxel infusion on Q3W regimen and had data available for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Pre-dose and at 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2 |
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| Secondary | Chemotherapy Phase: Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUCinf) of Carboplatin (Total and Free) | AUCinf is the area under the plasma concentration-time profile from time 0 extrapolated to infinite time. | Carboplatin PK parameter analysis set included all participants who had received at least one dose of study drug and who had at least one of the PK parameters of interest for carboplatin. Here "Overall number of participants analyzed" signifies participants who had data available for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Pre-dose and at 0.5, 1, 5, 6, 10, and 24 hours post carboplatin infusion on Day 1 of Cycle 2 |
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| Secondary | Chemotherapy Phase: Area Under the Concentration Time Curve From Time Zero to 24 Hours (AUC24) of Paclitaxel (QW Regimen) | AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24). | Paclitaxel PK parameter analysis set: all participants who received at least one dose of study drug and who had at least one of the PK parameters of interest for paclitaxel. Here "Overall number of participants analyzed" signifies participants who received Paclitaxel infusion on QW regimen and had data available for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Pre-dose (0 hour), 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2 |
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| Secondary | Chemotherapy Phase: Area Under the Concentration Time Curve From Time Zero to 24 Hours (AUC24) of Paclitaxel (Q3W Regimen) | AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24). | Paclitaxel PK parameter analysis set: all participants who had received at least one dose of study drug and who had at least one of the PK parameters of interest for paclitaxel. Here "Overall number of participants analyzed" signifies participants who received Paclitaxel infusion on Q3W regimen and had data available for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Pre-dose (0 hour), 1, 3, 4, 5, 6, 10, and 24 hours post paclitaxel infusion on Day 1 of Cycle 2 |
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| Secondary | Chemotherapy Phase: Area Under the Concentration Time Curve From Time Zero to 24 Hours (AUC24) of Carboplatin (Total and Free) | AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose. | Carboplatin PK parameter analysis set included all participants who had received at least one dose of study drug and who had at least one of the PK parameters of interest for carboplatin. Here "Overall number of participants analyzed" signifies participants who had data available for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Pre-dose (0 hour), 0.5, 1, 5, 6, 10, and 24 hours post carboplatin infusion on Day 1 of Cycle 2 |
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| Secondary | Maintenance Phase: Predose Plasma Concentration (Ctrough) of Avelumab | Ctrough is the concentration at the end of the dosing interval when avelumab was given as a Q2W regimen in the absence of carboplatin and paclitaxel following 1 cycle of avelumab dosing, i.e. before administration of drug on Day 1 of cycle 2. Ctrough of Avelumab in the absence of chemotherapy (i.e. in the maintenance phase) has been reported. The LLQ of avelumab was 0.20 micro-gram per milliliter (mcg/mL). Data for this outcome measure was not reported for reporting arms "PK: Chemotherapy + Avelumab followed by Avelumab" (since data was not planned to be collected 1 cycle after the initiation of avelumab dosing ) and "PK: Chemotherapy followed by Observation" (since avelumab was not administered in this arm and therefore data collection was not planned). | Avelumab PK concentration analysis set included all participants who had received at least one dose of study drug and who had at least one post-dose concentration measurement above the LLQ for avelumab. Here "Overall number of participants analyzed" signifies participants who had data available for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | mcg/mL | Pre-dose (0 hour) on Day 1 of Cycle 2 |
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| Secondary | Maintenance Phase: Maximum Plasma Concentration (Cmax) of Avelumab | Cmax is the concentration at the end of a 1 hour infusion, corresponding to the maximum plasma concentration of avelumab. The LLQ of avelumab was 0.20 mcg/mL. Data for this outcome measure was not reported for reporting arms "PK: Chemotherapy + Avelumab followed by Avelumab"(since data was not planned to be collected 1 cycle after the initiation of avelumab dosing ) and "PK: Chemotherapy followed by Observation" (since avelumab was not administered in this arm and therefore data collection was not planned). | Avelumab PK concentration analysis set included all participants who had received at least one dose of study drug and who had at least one post-dose concentration measurement above the LLQ for avelumab. Here "Overall number of participants analyzed" signifies participants who had data available for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | mcg/mL | End of avelumab infusion on Day 1 of Cycle 2 |
|
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| Secondary | Chemotherapy Phase: Maximum Plasma Concentration (Cmax) of Avelumab When Given With Paclitaxel and Carboplatin | Cmax is the concentration at the end of a 1 hour infusion, corresponding to the maximum plasma concentration of avelumab. The LLQ of avelumab was 0.20 mcg/mL. Data for this outcome measure was not reported for reporting arms "PK: Chemotherapy followed by Avelumab" (data not available for this OM as avelumab was not given along with paclitaxel and carboplatin in this arm) and "PK: Chemotherapy followed by Observation" (since avelumab was not administered in this arm and therefore data collection was not planned). | Avelumab PK concentration analysis set included all participants who had received at least one dose of study drug and who had at least one post-dose concentration measurement above the LLQ for avelumab. Here "Overall number of participants analyzed" signifies participants who had data available for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | mcg/mL | End of infusion on Day 1 of Cycle 2 |
|
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| Secondary | Chemotherapy Phase: Predose Plasma Concentration (Ctrough) of Avelumab When Given With Paclitaxel and Carboplatin | Ctrough is the concentration at the end of the dosing interval when avelumab was given as a Q2W regimen in the absence of carboplatin and paclitaxel following 1 cycle of avelumab dosing, i.e. before administration of drug on Day 1 of cycle 2. The LLQ of avelumab was 0.20 mcg/mL. Data for this outcome measure was not reported for reporting arms "PK: Chemotherapy followed by Avelumab" (data not available for this OM as avelumab was not given along with paclitaxel and carboplatin in this arm) and "PK: Chemotherapy followed by Observation" (since avelumab was not administered in this arm and therefore data collection was not planned). | Avelumab PK concentration analysis set included all participants who had received at least one dose of study drug and who had at least one post-dose concentration measurement above the LLQ for avelumab. Here "Overall number of participants analyzed" signifies only those participants who had data available for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | mcg/mL | Pre-dose (0 hour) on Day 1 of Cycle 2 |
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| Secondary | Number of Participants With Anti-Drug Antibodies (ADA) Against Avelumab by Never and Ever Positive Status | ADA against avelumab in serum samples was determined and reported separately for ADA never-positive and ADA ever-positive participants. Participants were considered ADA ever-positive if they had at least one positive (ADA titer greater than or equal to 60 with assay cut point of 1.12) ADA result at any time point during 36 months and were otherwise considered negative. Data for this outcome measure was not planned to be collected and analyzed for reporting arm "Chemotherapy followed by Observation", since, avelumab was not administered in this arm. | The immunogenicity analysis set included all participants who had received at least one dose of study drug and who had at least one ADA sample collected for avelumab in the avelumab containing arms. Here "Overall number of participants analyzed" signifies participants who had data available for this outcome measure. | Posted | Count of Participants | Participants | Up to 36 months |
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| Secondary | Number of Participants With Neutralizing Antibodies (nAb) Against Avelumab by Never and Ever Positive Status | nAb against avelumab in serum samples was determined and reported separately for nAb never-positive and nAb ever-positive participants. Participants were considered nAb ever-positive if they had at least one positive nAb results (less than or equal to cut point of 0.710 in qualitative competitive ligand binding assay) at any time point during 36 months. nAb never-positive participants were those who had at least one negative nAb results (greater than cut point of 0.710 in qualitative competitive ligand binding assay) at any time point. Data for this outcome measure was not planned to be collected and analyzed for reporting arm "Chemotherapy followed by Observation", since, avelumab was not administered in this arm. | The immunogenicity analysis set included all participants who had received at least one dose of study drug and who had at least one nAb sample collected for avelumab in the avelumab containing arms. Here "Overall number of participants analyzed" signifies participants who had data available for this outcome measure. | Posted | Count of Participants | Participants | Up to 36 months |
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| Secondary | Number of Participants With Positive Programmed Death Receptor-1 Ligand-1 (PD-L1) Biomarker Expression in Tumor Tissue as Assessed by Immunohistochemistry (IHC) | PD-L1 assessment was performed using immunohistochemistry. Participants were considered positive if their pretreatment tumor tissue sample demonstrated cell surface PD-L1 expression greater than or equal to (>=) 1 percent (%) tumor cells or >= 5% immune cells and were otherwise considered negative. | PD-L1 biomarker analysis set included all participants who had received at least one dose of study drug and who had at least one screening biomarker assessment for PD-L1. | Posted | Count of Participants | Participants | Up to 36 months |
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| Secondary | Number of Participants With Positive Tumor-Infiltrating Cluster of Differentiation 8 (CD8+) T Lymphocytes Expression in Tumor Tissue as Assessed by Immunohistochemistry (IHC) | CD8 assessment was performed using immunohistochemistry. Participants were considered positive if their pre-treatment tumor tissue sample demonstrated >= 1% CD8 positive cells and were otherwise considered negative. | CD8 biomarker analysis set included all participants who had received at least one dose of study drug and who had at least one screening biomarker assessment for CD8. | Posted | Count of Participants | Participants | Up to 36 months |
|
Baseline up to maximum duration of 36 months
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chemotherapy Followed by Avelumab | In chemotherapy phase (CP),based on investigator's decision,participants received either:paclitaxel 175 milligrams per square meter (mg/m2) intravenous (IV) infusion,followed by carboplatin dose at area under curve (AUC) 5 or 6,IV infusion (carboplatin dose (mg) = Target AUC (mg*min/mL) x (glomerular filtration rate[GFR] mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 (1 cycle=21 days). After completion of CP, participants without evidence of disease progression, received avelumab 10 mg/kg, over 1 hour IV infusion,once every 2 weeks on Days 1, 15, and 29 (1 cycle=42 days) in maintenance phase (MP) until confirmed progressive disease,unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months. | 34 | 328 | 92 | 328 | 320 | 328 |
| EG001 | Chemotherapy + Avelumab Followed by Avelumab | In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months. | 31 | 329 | 118 | 329 | 325 | 329 |
| EG002 | Chemotherapy Followed by Observation | In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months. | 20 | 334 | 64 | 334 | 317 | 334 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal abscess | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Abdominal wall abscess | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MMedDRA v22.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Anal haemorrhage | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Anastomotic leak | Injury, poisoning and procedural complications | MedDRA v22.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v22.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v22.1 | Non-systematic Assessment |
| |
| Breast cancer stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v22.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA v22.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Contrast media allergy | Immune system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA v22.1 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Depression suicidal | Psychiatric disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Diaphragmatic hernia | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Facial nerve disorder | Nervous system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v22.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Female genital tract fistula | Reproductive system and breast disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA v22.1 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA v22.1 | Non-systematic Assessment |
| |
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Gastrointestinal obstruction | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Hypercalcaemia of malignancy | Endocrine disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Hyperpyrexia | General disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Hypopituitarism | Endocrine disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Immune-mediated hepatitis | Hepatobiliary disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Incarcerated hernia | General disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA v22.1 | Non-systematic Assessment |
| |
| Infected lymphocele | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA v22.1 | Non-systematic Assessment |
| |
| Intestinal dilatation | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Intestinal haemorrhage | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Lymph gland infection | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Lymphocele | Vascular disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v22.1 | Non-systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Meningitis bacterial | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v22.1 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Pelvic infection | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Pelvic inflammatory disease | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Perforation | General disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Peripheral sensorimotor neuropathy | Nervous system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Peritoneal adhesions | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Persistent depressive disorder | Psychiatric disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Polymyositis | Musculoskeletal and connective tissue disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Procedural intestinal perforation | Injury, poisoning and procedural complications | MedDRA v22.1 | Non-systematic Assessment |
| |
| Pseudomembranous colitis | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Pulmonary infarction | Respiratory, thoracic and mediastinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Sarcoidosis | Immune system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Small intestinal haemorrhage | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Subclavian vein occlusion | Vascular disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA v22.1 | Non-systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Urogenital fistula | Renal and urinary disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Vaginal cuff dehiscence | Injury, poisoning and procedural complications | MedDRA v22.1 | Non-systematic Assessment |
| |
| Vaginal perforation | Reproductive system and breast disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Volvulus | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Vulval abscess | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA v22.1 | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Immune-mediated enterocolitis | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Essential hypertension | Vascular disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Gastrointestinal mucosal disorder | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA v22.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA v22.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA v22.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v22.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 8007181021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 16, 2018 | Sep 5, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| C000609138 | avelumab |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| Global deterioration of health status |
|
| No longer met eligibility criteria |
|
| Physician's decision |
|
| Progressive disease |
|
| Other |
|
| Withdrawal by Subject |
|
| Study terminated by sponsor |
|
| Lost to Follow-up |
|
| Physician Decision |
|
| Progressive disease |
|
| Study terminated by sponsor |
|
| Withdrawal by Subject |
|
| Global deterioration of health status |
|
| Other |
|
| Withdrawal by Subject |
|
| Study terminated by sponsor |
|
| Lost to Follow-up |
|
| Death leading to discontinuation |
|
| Study terminated by sponsor |
|
| Withdrawal by Subject |
|
| Other |
|
| Male |
|
| American Indian or Alaska Native |
|
| Asian |
|
| White |
|
| Other |
|
| Log Rank |
Analysis was performed using a Cox's Proportional Hazard model stratified by the randomization strata and a stratified log-rank test. |
| 0.7935 |
One-sided log-rank test was used. |
| Hazard Ratio (HR) |
| 1.14 |
| 2-Sided |
| 95 |
| 0.832 |
| 1.565 |
| Superiority |
In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months. |
| OG002 | Chemotherapy Followed by Observation | In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months. |
|
|
|
| OG001 | Chemotherapy + Avelumab Followed by Avelumab | In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months. |
| OG002 | Chemotherapy Followed by Observation | In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months. |
|
|
|
| OG001 | Chemotherapy + Avelumab Followed by Avelumab | In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months. |
| OG002 | Chemotherapy Followed by Observation | In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months. |
|
|
| OG001 | Chemotherapy + Avelumab Followed by Avelumab | In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months. |
| OG002 | Chemotherapy Followed by Observation | In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months. |
|
|
| OG001 | Chemotherapy + Avelumab Followed by Avelumab | In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months. |
| OG002 | Chemotherapy Followed by Observation | In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months. |
|
|
| OG001 | Chemotherapy + Avelumab Followed by Avelumab | In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months. |
| OG002 | Chemotherapy Followed by Observation | In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months. |
|
|
| OG001 | Chemotherapy + Avelumab Followed by Avelumab | In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months. |
| OG002 | Chemotherapy Followed by Observation | In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months. |
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| OG001 | Chemotherapy + Avelumab Followed by Avelumab | In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months. |
| OG002 | Chemotherapy Followed by Observation | In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months. |
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| OG001 | Chemotherapy + Avelumab Followed by Avelumab | In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months. |
| OG002 | Chemotherapy Followed by Observation | In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months. |
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| OG001 | Chemotherapy + Avelumab Followed by Avelumab | In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months. |
| OG002 | Chemotherapy Followed by Observation | In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months. |
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| OG001 | Chemotherapy + Avelumab Followed by Avelumab | In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months. |
| OG002 | Chemotherapy Followed by Observation | In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months. |
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| OG001 | Chemotherapy + Avelumab Followed by Avelumab | In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months. |
| OG002 | Chemotherapy Followed by Observation | In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months. |
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| OG001 | Chemotherapy + Avelumab Followed by Avelumab | In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months. |
| OG002 | Chemotherapy Followed by Observation | In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months. |
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| OG001 | Chemotherapy + Avelumab Followed by Avelumab | In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months. |
| OG002 | Chemotherapy Followed by Observation | In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months. |
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| OG001 | Chemotherapy + Avelumab Followed by Avelumab | In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months. |
| OG002 | Chemotherapy Followed by Observation | In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months. |
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| OG001 | Chemotherapy + Avelumab Followed by Avelumab | In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months. |
| OG002 | Chemotherapy Followed by Observation | In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months. |
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| OG001 | Chemotherapy + Avelumab Followed by Avelumab | In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months. |
| OG002 | Chemotherapy Followed by Observation | In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months. |
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| OG001 | Chemotherapy + Avelumab Followed by Avelumab | In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months. |
| OG002 | Chemotherapy Followed by Observation | In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months. |
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| OG002 | PK: Chemotherapy Followed by Observation | In chemotherapy phase, participants received paclitaxel Q3W (or QW on Day 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles. |
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| OG002 | PK: Chemotherapy Followed by Observation | In chemotherapy phase, participants received paclitaxel Q3W (or QW on Day 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles. |
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| PK: Chemotherapy Followed by Observation |
In chemotherapy phase, participants received paclitaxel Q3W (or QW on Day 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles. |
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| OG002 | PK: Chemotherapy Followed by Observation | In chemotherapy phase, participants received paclitaxel Q3W (or QW on Day 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles. |
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| OG002 | PK: Chemotherapy Followed by Observation | In chemotherapy phase, participants received paclitaxel Q3W (or QW on Day 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles. |
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| OG002 | PK: Chemotherapy Followed by Observation | In chemotherapy phase, participants received paclitaxel Q3W (or QW on Day 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles. |
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| OG002 | PK: Chemotherapy Followed by Observation | In chemotherapy phase, participants received paclitaxel Q3W (or QW on Day 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles. |
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| OG002 | PK: Chemotherapy Followed by Observation | In chemotherapy phase, participants received paclitaxel Q3W (or QW on Day 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles. |
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| OG002 | PK: Chemotherapy Followed by Observation | In chemotherapy phase, participants received paclitaxel Q3W (or QW on Day 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles. |
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In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W along with avelumab Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W (on Days 1, 15 and 29 of each 42 day cycle).
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| Immunogenicity: Chemotherapy + Avelumab Followed by Avelumab |
In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W along with avelumab Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W (on Days 1, 15 and 29 of each 42 day cycle). |
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| OG001 | Chemotherapy + Avelumab Followed by Avelumab | In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months. |
| OG002 | Chemotherapy Followed by Observation | In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months. |
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| OG001 | Chemotherapy + Avelumab Followed by Avelumab | In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose [milligrams](mg) = Target AUC (mg*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months. |
| OG002 | Chemotherapy Followed by Observation | In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose [milligrams](mg) = Target AUC [milligrams*minute per milliliter] (mg*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months. |
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